Quality Systems Associate

Grifols

. Perform quality assurance and training functions under the direct supervision of the Quality Systems Manager .

Posted 9/24/2026full-timeBryan • Texas • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates proficiency in quality assurance processes, including cGMP compliance, documentation review, and root-cause analysis. Capable of conducting training and ensuring adherence to regulatory requirements while maintaining high standards of quality and safety.

Highest-signal resume keywords

Quality AssuranceCGMP ComplianceRoot-Cause AnalysisDonor Center Technician CertificationSOP Understanding

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ControlDocumentation ReviewMathematics ProficiencyBiological Fluids HandlingLaboratory Equipment Use

Soft Skills

Interpersonal CommunicationOrganizational SkillsProblem-Solving SkillsAttention to Detail

Tools & Technologies

Quality SystemsTraining Records Management

Certifications & Qualifications

Donor Center Technician Certification

Industry Keywords

FDA RegulationsCGMPSOPsQuality ComplianceDonor Safety

About the role

Key responsibilities & impact

Perform quality assurance and training functions under the direct supervision of the Quality Systems Manager
Complete weekly reviews of equipment QC and maintenance records
Document, investigate and perform root-cause analysis for deviations and customer complaints related to product quality or donor safety
Inspect and release incoming supplies
Investigate and report supplies that do not meet quality specifications before use
Perform documentation review for unsuitable test results
Assist the Quality Systems Manager in ensuring cGMP regulations, SOPs and regulatory requirements are followed
Perform all product release activities
Review lookback information and documentation
Review waste shipment documentation
Review unexpected plasmapheresis events and related donor documentation
Review electronic donor chart exceptions affecting donor eligibility, donor safety or product quality
Review donor deferral notifications from competitor centers
Review plasma processing documentation for proper freezing, storage and handling
Create, maintain and audit training records and files
Perform employee training observations to verify staff competency before independent work
Conduct required training for Center Notifications, Corporate Directives, SOP changes and initial SOP implementations
When the Quality Systems Manager is absent, review and approve deferred donor reinstatement activities
Assist with completion of the internal donor center audit
Review monthly trending reports
Review donor adverse-event reports and related documentation
Conduct training addressing donor center corrective and preventive measures
Communicate issues identified during reviews to the CQM

Requirements

What you’ll need

High school diploma or GED
Typically requires no previous related experience
Must obtain state licensures or certifications if applicable
Certified and maintains certification as a Donor Center Technician
Developing command of interpersonal communication, organizational and problem-solving skills
Ability to understand FDA regulations
Strong integrity and commitment to quality and compliance
Good knowledge of mathematics
Legible handwriting
Proficiency with computers
Ability to work flexible scheduling to meet business needs
Ability to understand and follow SOPs and protocols
Basic understanding of cGMP and quality systems
Ability to spend hours sitting and reviewing documentation for accuracy
Good organizational skills and attention to detail
Ability to perform primary responsibilities of the Quality Associate role proficiently
Ability to work with biological fluids, laboratory equipment and extreme cold conditions
Ability to lift 15 pounds, with a maximum lift of 50 pounds
Hearing acuity essential
Correctable near and far vision requirements
Ability to communicate and understand spoken information
Ability to work independently with little guidance
Ability to relate sensitive information to diverse groups

Benefits

Comp & perks

Equal employment opportunities and consideration consistent with applicable laws
Personal protective equipment provided/required, including protective eyewear, garments, gloves and cold-gear